- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01744080
Rotator Cuff Injury to Surgery (RC-IS)
Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery
연구 개요
상세 설명
Consented patients will undergo a pre-operative assessment conducted by a study physiotherapist, including the following: 1) demographic information (age, gender, height, weight, smoking status, employment, recreational activities, time of injury, etc.); 2) shoulder ROM, 3) shoulder strength using a handheld dynamometer, and 4) subjective shoulder-specific outcome measures which include the Western Ontario Rotator Cuff Score (WORC), American Shoulder and Elbow Score (ASES), and Simple Shoulder Test (SST). Measurement of tear size will also be documented by an experienced radiologist from the initial MRI or ultrasound.
Patients will undergo initial consultation with the orthopaedic surgeon to confirm suitability for surgical management. If deemed appropriate to continue as a participant, the individual participants will be randomized to one of the two study groups. If in the Expedited group, the patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sports medicine physician. If randomized to the Control or 'Typical Wait Time' Group, surgery will take place no earlier than 9 months and no later than 12 months after the sports medicine physician consult.
Just prior to surgery, a second diagnostic imaging test will take place, either ultrasound or MRI, to document progress in tear size and any secondary pathology in the control group. Diagnostic test findings will be confirmed intraoperatively. All rotator cuff repairs will be performed by one of four fellowship trained orthopaedic surgeons.
The control study group will be sent the subjective questionnaires at 8 week intervals while they are waiting for surgery. Post-surgery study follow-ups will take place at 6, 12, and 24 months for both groups. All patients will be provided with the same rehabilitation protocol including pain management, range of motion and strengthening exercises. The same data as that collected pre-surgery will be repeated as well as any occurrences of failure of the repair. Failure of the repair is defined as ongoing severe pain, limited ROM, and/or decreased strength. If a failure occurs, follow-ups will continue until 24 months following failure or 24 months following revision surgery, if performed.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3M3E4
- Pan Am Clinic
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Between the ages of 45 and 70 years old
- Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)
Exclusion Criteria:
- Presence of a tear of the subscapularis and/or teres minor;
- Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
- Patient has undergone previous RC surgery to the affected shoulder;
- Patient has an active WCB Claim or prior claim related to their shoulder;
- Previous major joint trauma, infection, or avascular necrosis;
- Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
- Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
- Major medical illness where life expectancy is less than 2 years;
- Does not speak/read/understand English;
- No fixed address or means of contact;
- Unwillingness to complete necessary follow-ups
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Early Surgery
|
Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
|
|
실험적: Regular Wait Time
|
Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Western Ontario Rotator Cuff
기간: 24 months
|
WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems.
Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
|
24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES)
기간: 24 months
|
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function.
Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
|
24 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Injury to Surgery Time
기간: 24 months
|
Time will be calculated from initial injury to consultation to surgery.
|
24 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jeff Leiter, MSc, PhD, Pan Am Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
회전근개파열에 대한 임상 시험
-
Contamac LtdAndre Vision and Device Research; The Contact Lens Center at Optique; Premiere Vision Group; Havasu Eye Center완전한
-
Smith & Nephew, Inc.완전한비구순 파열 | 슬랩 병변 | 방카르트 병변 | 회전근개 파열 | Labral Tear, Glenoid | 전방 어깨 불안정성미국
-
Rush University Medical Center모병
-
Zimmer Biomet종료됨
-
The Cooper Health SystemNew Jersey Health Foundation초대로 등록
Early Surgery에 대한 임상 시험
-
Stryker Craniomaxillofacial모집하지 않고 적극적으로하악 골절 | 안면 골절 | 상악 골절 | 악교정 수술 절차미국
-
Fu Wai Hospital, Beijing, ChinaThe First Affiliated Hospital with Nanjing Medical University모집하지 않고 적극적으로
-
Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.완전한
-
Human Development Research Foundation, PakistanUniversity of Liverpool; Institute of Psychiatry, WHO Collaborating Center for Mental Health...완전한우울증 | 불안 | 심리적 고통 | 정서적 문제파키스탄
-
Drexel UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)모병
-
Hôpital le VinatierHospices Civils de Lyon; University Hospital, Strasbourg, France; Versailles Hospital; Centre...완전한